Doubleblind randomized multicenter trial to investigate the influence of dimenhydrinate suppositories vs. placebo on oral rehydration in infants and children with infectious enteritis and vomiting - VomED
- Conditions
- Infectious enteritis with vomitingMedDRA version: 8.1Level: PTClassification code 10058839Term: Enteritis infectious
- Registration Number
- EUCTR2005-003943-30-DE
- Lead Sponsor
- niversity of Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
Acute vomiting started 8-24 hours prior the inclusion due to suggested infectious enteritis with at least 2 episodes of vomiting in the last 12 hours
age: 6 months - 5 years
weight over 7000g
outpatients
informed consent of at least one caregiver
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Contraindications against the study drug
receipts of the following medications:
Treatment with medicinal products with suspected interactions with dimenhydrinat,
Treatment with antiemetics or secretion inhibitors
severe disease with one of the following criteria:
bloody stool (with this disease)
suggested requirement of i.v. rehydration
Confirmed weight loss of more than 5% body weight
Metabolic acidosis (i.e. pH < 7,25) and/or electrolyte disturbances (measured by blood test in the emergency clinic originated in the responsibility of the investigator)
Suspected lack of cooperation and compliance by the patient or the caregiver(s) or linguistic problems of the parents
Participation in other medical trials
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method